N-Terminal Pro-brain Natriuretic Peptide Hormone and Pers... | NCT00443859

Studies
N-Terminal Pro-brain Natriuretic Peptide Hormone and Persistent Pulmonary Hypertension

NCT00443859

Sponsor

Christiana Care Health Services

Status

Terminated

Last Update Posted

Jul 11, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Persistent Pulmonary Hypertension of Newborn

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim analysis showed greater variablility in NT-proBNP findings than anticipated.

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Mar 2, 2007

First Submission Date that Met QC Criteria

Mar 2, 2007

First Posted Date

Mar 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2016

Last Update Posted Date

Jul 11, 2016Estimated

Name	Class
Thomas Jefferson University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Babies who are suspected of having persistent pulmonary hypertension (PPHN) will be included in this study. PPHN is a condition in which the blood is restricted from flowing to the lungs in a normal way making it hard for babies to breath and placing strain on the heart. This study will observe whether certain hormones that measure stress (N-terminal pro-brain natriuretic peptide) can help determine how well a baby will do when they have PPHN.

Detailed Description

PPHN occurs in infant > or = 34 weeks gestation and is characterized by an elevation in pulmonary vascular resistance (PVR) and right-to-left shunting of the blood at the atrial, ductal, and pulmonary levels, leading to hypoxemia. Management of these infants is complex (and the clinical course) is often difficult to predict.

Brain natriuretic peptide (BNP) is a cardiac hormone that is secreted from cardiac myocytes and cardiac fibroblasts. Upon activation, the prohormone is cleaved into a biologically active BNP and an inactive N-terminal proBNP (NT-proBNP). BNP and NT-proBNP levels are increasingly being used for diagnostic purpose in adults and have been correlated to adult pulmonary hypertension. Multiples studies have been performed to determine normal values for NT-proBNP in the pediatric population. One study measured NT-proBNP levels in umbilical cord blood during the second trimester and at delivery of uncomplicated pregnancies and determined normal reference values of NT-proBNP. It is thought that NT-proBNP has potential for use in term infants with PPHN.

The objective of this research is to correlate NT-proBNP levels to left ventricular dysfunction in term infants with PPHN. Secondarily, we want to assess the possible use of NT-proBNP to predict response to inhaled nitric oxide and the ability to successfully wean off inhaled nitric oxide.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Actual

Label	Type	Description	Intervention Names
PPHN		Infants with persistent pulmonary hypertension (PPHN)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>/= 34 weeks gestation at birth
clinical diagnosis of PPHN

Exclusion Criteria:

newborns with evidence of structural heart disease, congenital anomalies and prior use of inhaled nitric oxide.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

All infants who are admitted to the NICU with a diagnoses of PPHN.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Euming Chong, MD	Christiana Hospital / Thomas Jefferson University Hospital	Principal Investigator
Constance Andrejko, DO	Christiana Hospital / Thomas Jefferson University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Hospital		Newark	Delaware	19718	United States
Thomas Jefferson University

Condition Browse Module

MeSH Terms

ID	Term
D010547	Persistent Fetal Circulation Syndrome

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D007232	Infant, Newborn, Diseases

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Browse Branches

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